FibromyalgiaNCT05058911
Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia
A study testing Internet-delivered exposure-based cognitive behavior therapy and Internet-delivered traditional cognitive behavior therapy in people with Fibromyalgia, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
Fibromyalgia (FM) is a common medical condition characterized by chronic generalized musculoskeletal pain, fatigue, and a series of additional somatic and psychiatric problems that give rise to distress, functional impairment, and substantial societal costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Internet-delivered exposure-based cognitive behavior therapy and Internet-delivered traditional cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 2 sitesSweden
- Study dates
- 22 Sep 2021to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living in Sweden
- Access to the internet
- Completed pre-treatment assessment
- If on psychotropic medication, dose kept stable for at least 4 weeks before randomization and the participant agrees to keep it constant during treatment
Who cannot join
- Severe depression (≥ 30 on the Montgomery Åsberg Depression Rating Scale-Self Rated [MADRS-S] at screening)
- Suicidal ideation (≥ 4 on the suicide item of the MADRS-S at screening),
- Psychosis
- Alcohol or substance use disorder as primary diagnosis or likely to severely interfere with treatment
- Ongoing psychological treatment
- Pregnancy (>29 wk gestation)
- Another somatic condition that requires immediate treatment and/or is deemed to be the primary condition
- Insufficient knowledge of the Swedish language or insufficient computer skills to benefit from the text-based online treatment.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Karolinska Institutet
Solna, 17177
Uppsala University
Uppsala, 75105
About this study
Official title: Randomized Controlled Trial of Internet-delivered Exposure-based Cognitive Behavior Therapy vs. Internet-delivered Traditional Cognitive Behavior Therapy for Patients With Fibromyalgia
Fibromyalgia (FM) is a common medical condition characterized by chronic generalized musculoskeletal pain, fatigue, and a series of additional somatic and psychiatric problems that give rise to distress, functional impairment, and substantial societal costs. The most extensively evaluated treatment for FM is traditional cognitive behavior therapy (T-CBT) which typically appears to have small to moderate effects when compared to waitlist, attention control, treatment as usual or other active nonpharmacological therapies. Internet-delivered exposure-based cognitive behavior therapy (Exp-CBT) where the patient willingly and systematically engages with stimuli associated with pain and pain-related distress has shown promising controlled effects versus a waiting-list but has never been compared to T-CBT in a randomized controlled trial. In this randomized controlled trial, self-recruited adults with FM (N=260) are randomly assigned (1:1) to 10 weeks of internet-delivered Exp-CBT or internet-delivered T-CBT and complete self-report questionnaires to measure symptoms and therapeutic processes up to 12 months after treatment. Primary outcome is the relative effect of Exp-CBT and T-CBT on FM severity as modelled using linear mixed models fitted on weekly Fibromyalgia Impact Questionnaire sum scores over the treatment period, testing the hypothesis of Exp-CBT superiority based on the coefficient for the time × group interaction. The investigators will also calculate the number of treatment completers in each treatment condition, defined as having commenced module five out of eight treatment modules. Cost-effectiveness and mediational processes are investigated in secondary analyses. The investigators expect this trial to be of notable clinical significance as it will provide valuable information about the value of Exp-CBT in helping patients with FM as compared to using other interventions.
Read the detailed description
FM is a common problem with substantial negative consequences. The most widely evaluated psychological treatment for FM is T-CBT which usually has small to moderate controlled effects on pain, mood and functional impairment. Based on one pilot study and one wailist-controlled RCT, Exp-CBT appears to have promising effects on FM but this treatment has not yet been compared to an active control condition. The present study aims to compare internet-delivered Exp-CBT to internet-delivered T-CBT in a randomized controlled trial.
Participants in Exp-CBT and T-CBT are encouraged to work with self-help texts and complete regular homework exercises via a secure treatment platform. Both treatments are 10 weeks long, equally exhaustive, and involve approximately the same level of therapist support.
Primary outcome is the relative effect of Exp-CBT and T-CBT on FM severity as modelled using linear mixed models fitted on weekly Fibromyalgia Impact Questionnaire sum scores over the treatment period, testing the hypothesis of Exp-CBT superiority based on the coefficient for the time × group interaction. The investigators will also calculate the number of treatment completers in each treatment condition, defined as having commenced module five out of eight treatment modules. Detailed information regarding analysis of clinical efficacy is provided in the supplementary file.
In addition to clinical efficacy, the investigators will also investigate cost-effectiveness and mediational processes. The primary hypothesis is that Exp-CBT is significantly more efficacious than T-CBT in reducing FM severity, i.e., the Fibromyalgia Impact Questionnaire (FIQ) composite score indicative of symptoms and functional status, from the baseline assessment to the 10-week assessment.
- Conditions
- Fibromyalgia
- Being tested
- Internet-delivered exposure-based cognitive behavior therapy, Internet-delivered traditional cognitive behavior therapy
- Keywords
- cognitive behavior therapy, randomized controlled trial, internet-delivered treatment
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered exposure-based cognitive behavior therapyBehavioural
Also called Exp-CBT
The primary treatment component is exposure to stimuli (situations and activities) that give rise to pain, distress, and unwanted emotional responses. The treatment proceeds in accordance with functional analysis. Exercises are tailored for the patient so that, for example, individuals whose main coping strategy is to be overly active (i.e., persistence behavior) are encouraged to sit down and observe pain and other aversive bodily sensations as they arise. The protocol also includes regular exercises where the participant is encouraged to observe and name physical sensations without acting on them.
Internet-delivered traditional cognitive behavior therapyBehavioural
Also called T-CBT
This treatment is based on components typical of T-CBT for FM, such as relaxation, activity planning or pacing, cognitive restructuring techniques and stress management strategies.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered exposure-based cognitive behavior therapy (Exp-CBT) | Experimental | 10-week self-help treatment delivered via a secure online platform, with regular therapist support. Receives: Behavioral: Internet-delivered exposure-based cognitive behavior therapy |
| Internet-delivered traditional cognitive behavior therapy (T-CBT) | Active comparator | 10-week self-help treatment delivered via a secure online platform, with regular therapist support. Receives: Behavioral: Internet-delivered traditional cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FM severity over the main phase, as modelled using data from all 11 assessments from the pre-treatment assessment, weekly to the primary endpoint (10 weeks).
The Fibromyalgia Impact Questionnaire, FIQ. Self-rated, range 0-100. Higher score indicate higher FM severity.
Measured: Screening, Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Secondary outcomes (8)
Change in pain over the main phase, as modelled using data from all 11 assessments from the pre-treatment assessment, weekly to the primary endpoint (10 weeks).
The Fibromyalgia Impact Questionnaire, FIQ-Pain subscale. Self-rated, range 0 to 10, a higher score indicates more pain.
Measured: Screening, Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Change in pain over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
Brief Pain Inventory-Short Form, BPI-Sf. Self-rated, range 0-10. A higher score indicates more pain.
Measured: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-MFU assessments.
Change in fatigue over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
Fatigue Severity Scale, FSS. Self-rated, range 9-63. A higher score indicates greater fatigue severity
Measured: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Change in anxiety over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
GAD-2. Self-rated, range: 0-6. A higher score indicates more general anxiety.
Measured: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Change in depression over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
PHQ-2. Self-rated, range: 0-6. A higher score indicates more depressive symptoms.
Measured: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Change in functional impairment over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks).
12-item WHO Disability Assessment Schedule 2.0, WHODAS 2.0. Self-rated, range: 0-100. A higher score indicates more disability.
Measured: Pre-treatment, 10 weeks, Secondary analyses incorporate 6- and 12-months follow-up assessments.
Change in quality of life over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks).
Brunnsviken Brief Quality of Life Inventory, BBQ. Self-rated, range 0 to 96, a higher score indicates better quality of life
Measured: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Global impression of perceived change at post-treatment
Patient Global Impression of Change, PGIC. Self-rated, range no change [or condition has got worse] to a great deal better, and a considerable improvement that has made all the difference
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start22 Sep 2021
- Primary completion1 Jun 2022
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with repeated measurments and two conditions: the experimental group (Exp-CBT) and an active control group (T-CBT).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Responsible party
- Principal investigator, Maria Hedman-Lagerlöf, Karolinska Institutet
- Investigators
- Maria Hedman-Lagerlöf, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058911
- Sponsor's protocol ID
- 2021-03302
- Status last verified
- Nov 2023
- First submitted
- 8 Sep 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hedman-Lagerlof M, Hedman-Lagerlof E, Buhrman M, Axelsson E. Cost-effectiveness and cost-utility of exposure-based vs. traditional cognitive behavior therapy for fibromyalgia: Results from a randomized controlled trial. J Pain. 2025 May;30:105375. doi: 10.1016/j.jpain.2025.105375. Epub 2025 Mar 17.
PubMed 40107589Hedman-Lagerlof M, Gasslander N, Ahnlund Hoffmann A, Bragesjo M, Etzell A, Ezra S, Frostell E, Hedman-Lagerlof E, Ivert C, Liliequist B, Ljotsson B, Hoppe JM, Palmgren J, Spansk E, Sundstrom F, Sarnholm J, Tzavara G, Buhrman M, Axelsson E. Effect of exposure-based vs traditional cognitive behavior therapy for fibromyalgia: a two-site single-blind randomized controlled trial. Pain. 2024 Jun 1;165(6):1278-1288. doi: 10.1097/j.pain.0000000000003128. Epub 2023 Dec 15.
PubMed 38131181Hoffmann AA, Frostell E, Hedman-Lagerlof M, McCracken LM, Axelsson E. Psychometric evaluation of the Pain Vigilance and Awareness Questionnaire (PVAQ) in fibromyalgia: Confirmatory factor analysis and the development of a Swedish 8-item version. Eur J Pain. 2024 Mar;28(3):396-407. doi: 10.1002/ejp.2188. Epub 2023 Sep 27.
PubMed 37759360
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Internet-delivered Exposure-based Cognitive Behavior Therapy vs. Internet-delivered Traditional Cognitive Behavior Therapy for Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT05058911
- Acronym / sponsor ID
- 2021-03302
- Conditions
- Fibromyalgia
- Keywords
- cognitive behavior therapy, randomized controlled trial, internet-delivered treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fibromyalgia (FM) is a common medical condition characterized by chronic generalized musculoskeletal pain, fatigue, and a series of additional somatic and psychiatric problems that give rise to distress, functional impairment, and substantial societal costs. The most extensively evaluated treatment for FM is traditional cognitive behavior therapy (T-CBT) which typically appears to have small to moderate effects when compared to waitlist, attention control, treatment as usual or other active nonpharmacological therapies. Internet-delivered exposure-based cognitive behavior therapy (Exp-CBT) where the patient willingly and systematically engages with stimuli associated with pain and pain-related distress has shown promising controlled effects versus a waiting-list but has never been compared to T-CBT in a randomized controlled trial. In this randomized controlled trial, self-recruited adults with FM (N=260) are randomly assigned (1:1) to 10 weeks of internet-delivered Exp-CBT or internet-delivered T-CBT and complete self-report questionnaires to measure symptoms and therapeutic processes up to 12 months after treatment. Primary outcome is the relative effect of Exp-CBT and T-CBT on FM severity as modelled using linear mixed models fitted on weekly Fibromyalgia Impact Questionnaire sum scores over the treatment period, testing the hypothesis of Exp-CBT superiority based on the coefficient for the time × group interaction. The investigators will also calculate the number of treatment completers in each treatment condition, defined as having commenced module five out of eight treatment modules. Cost-effectiveness and mediational processes are investigated in secondary analyses. The investigators expect this trial to be of notable clinical significance as it will provide valuable information about the value of Exp-CBT in helping patients with FM as compared to using other interventions.
Detailed description
FM is a common problem with substantial negative consequences. The most widely evaluated psychological treatment for FM is T-CBT which usually has small to moderate controlled effects on pain, mood and functional impairment. Based on one pilot study and one wailist-controlled RCT, Exp-CBT appears to have promising effects on FM but this treatment has not yet been compared to an active control condition. The present study aims to compare internet-delivered Exp-CBT to internet-delivered T-CBT in a randomized controlled trial.
Participants in Exp-CBT and T-CBT are encouraged to work with self-help texts and complete regular homework exercises via a secure treatment platform. Both treatments are 10 weeks long, equally exhaustive, and involve approximately the same level of therapist support.
Primary outcome is the relative effect of Exp-CBT and T-CBT on FM severity as modelled using linear mixed models fitted on weekly Fibromyalgia Impact Questionnaire sum scores over the treatment period, testing the hypothesis of Exp-CBT superiority based on the coefficient for the time × group interaction. The investigators will also calculate the number of treatment completers in each treatment condition, defined as having commenced module five out of eight treatment modules. Detailed information regarding analysis of clinical efficacy is provided in the supplementary file.
In addition to clinical efficacy, the investigators will also investigate cost-effectiveness and mediational processes. The primary hypothesis is that Exp-CBT is significantly more efficacious than T-CBT in reducing FM severity, i.e., the Fibromyalgia Impact Questionnaire (FIQ) composite score indicative of symptoms and functional status, from the baseline assessment to the 10-week assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial with repeated measurments and two conditions: the experimental group (Exp-CBT) and an active control group (T-CBT).
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered exposure-based cognitive behavior therapy (Exp-CBT) | Experimental | Behavioral: Internet-delivered exposure-based cognitive behavior therapy10-week self-help treatment delivered via a secure online platform, with regular therapist support. |
| Internet-delivered traditional cognitive behavior therapy (T-CBT) | Active comparator | Behavioral: Internet-delivered traditional cognitive behavior therapy10-week self-help treatment delivered via a secure online platform, with regular therapist support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Living in Sweden
- Access to the internet
- Completed pre-treatment assessment
- If on psychotropic medication, dose kept stable for at least 4 weeks before randomization and the participant agrees to keep it constant during treatment
Key exclusion criteria (8 listed)
- Severe depression (≥ 30 on the Montgomery Åsberg Depression Rating Scale-Self Rated [MADRS-S] at screening)
- Suicidal ideation (≥ 4 on the suicide item of the MADRS-S at screening),
- Psychosis
- Alcohol or substance use disorder as primary diagnosis or likely to severely interfere with treatment
- Ongoing psychological treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered exposure-based cognitive behavior therapyAlso: Exp-CBTThe primary treatment component is exposure to stimuli (situations and activities) that give rise to pain, distress, and unwanted emotional responses. The treatment proceeds in accordance with functional analysis. Exercises are tailored for the patient so that, for example, individuals whose main coping strategy is to be overly active (i.e., persistence behavior) are encouraged to sit down and observe pain and other aversive bodily sensations as they arise. The protocol also includes regular exercises where the participant is encouraged to observe and name physical sensations without acting on them. | Behavioural | Internet-delivered exposure-based cognitive behavior therapy (Exp-CBT) |
| Internet-delivered traditional cognitive behavior therapyAlso: T-CBTThis treatment is based on components typical of T-CBT for FM, such as relaxation, activity planning or pacing, cognitive restructuring techniques and stress management strategies. | Behavioural | Internet-delivered traditional cognitive behavior therapy (T-CBT) |
Primary outcome
Change in FM severity over the main phase, as modelled using data from all 11 assessments from the pre-treatment assessment, weekly to the primary endpoint (10 weeks).
Time frame: Screening, Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
The Fibromyalgia Impact Questionnaire, FIQ. Self-rated, range 0-100. Higher score indicate higher FM severity.
8 secondary outcomes
Change in pain over the main phase, as modelled using data from all 11 assessments from the pre-treatment assessment, weekly to the primary endpoint (10 weeks).
Time frame: Screening, Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Change in pain over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
Time frame: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-MFU assessments.
Change in fatigue over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
Time frame: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Change in anxiety over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
Time frame: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Change in depression over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks)
Time frame: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Change in functional impairment over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks).
Time frame: Pre-treatment, 10 weeks, Secondary analyses incorporate 6- and 12-months follow-up assessments.
Change in quality of life over the main phase, as modelled using data from the pre-treatment assessment and primary endpoint (10 weeks).
Time frame: Pre-treatment, 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.
Global impression of perceived change at post-treatment
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Derived from this study: PubMed 40107589Hedman-Lagerlof M, Hedman-Lagerlof E, Buhrman M, Axelsson E. Cost-effectiveness and cost-utility of exposure-based vs. traditional cognitive behavior therapy for fibromyalgia: Results from a randomized controlled trial. J Pain. 2025 May;30:105375. doi: 10.1016/j.jpain.2025.105375. Epub 2025 Mar 17.
- Derived from this study: PubMed 38131181Hedman-Lagerlof M, Gasslander N, Ahnlund Hoffmann A, Bragesjo M, Etzell A, Ezra S, Frostell E, Hedman-Lagerlof E, Ivert C, Liliequist B, Ljotsson B, Hoppe JM, Palmgren J, Spansk E, Sundstrom F, Sarnholm J, Tzavara G, Buhrman M, Axelsson E. Effect of exposure-based vs traditional cognitive behavior therapy for fibromyalgia: a two-site single-blind randomized controlled trial. Pain. 2024 Jun 1;165(6):1278-1288. doi: 10.1097/j.pain.0000000000003128. Epub 2023 Dec 15.
- Derived from this study: PubMed 37759360Hoffmann AA, Frostell E, Hedman-Lagerlof M, McCracken LM, Axelsson E. Psychometric evaluation of the Pain Vigilance and Awareness Questionnaire (PVAQ) in fibromyalgia: Confirmatory factor analysis and the development of a Swedish 8-item version. Eur J Pain. 2024 Mar;28(3):396-407. doi: 10.1002/ejp.2188. Epub 2023 Sep 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Hedman-Lagerlöf, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered exposure-based cognitive behavior therapy and Internet-delivered traditional cognitive behavior therapy in people with Fibromyalgia, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FM severity over the main phase, as modelled using data from all 11 assessments from the pre-treatment assessment, weekly to the primary endpoint (10 weeks). (time frame: Screening, Pre-treatment, weekly up to 10 weeks. Secondary analyses incorporate 6- and 12-months follow-up assessments.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05058911, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.